TransEnterix files expanded 510(k) application for Senhance robotic platformTransEnterix (NYSE:TRXC) said today it filed an FDA 510(k) submission looking to expand the indications for its Senhance robotic surgical platform to include laparoscopic inguinal hernia and laparoscopic cholecystectomy surgeries.
The Research Triangle Park, N.C.-based company said that with the additional indications, its Senhance system would be cleared for use in the most common abdominal surgeries in the US in general surgery, gynecology and colorectal surgery.
TransEnterix said it is hopeful to receive approval for the expanded indications by the mid-year.
“We have performed more than 150 Senhance surg...Source: Mass Device - February 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Robotics Surgical TransEnterix Source Type: news

Why it's too soon to classify gaming addiction as a mental disorderConcerns over the addictive properties of video games are reasonable but there is a lack of rigorous research behind the WHO ’s expected classificationVideo games played on smartphones, tablets, computers and consoles have been a popular form of leisure for some time now. In Europe,recent figures indicate that games are played by more than two thirds of children and adolescents, and a substantial number of adults now play games – 38% in the UK, 64% in France, 56% in Germany and 44% in Spain.The WHO will publish the next revision of its manual – the International Classification of Diseases (ICD-11) –...Source: Guardian Unlimited Science - February 14, 2018 Category: Science Authors: Andy Przybylski and Amy Orben Tags: Science Psychology Games Controversies Mental health Source Type: news

Bayer gets FDA rebuke for drug production in GermanyFRANKFURT (Reuters) - Bayer said it had received a warning letter from the U.S. Food and Drug Administration over how it handled production of some drugs at its Leverkusen, Germany headquarters. (Source: Reuters: Health)Source: Reuters: Health - February 14, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

What Growth Charts Are Best?Discussion
“The value of growth assessment is thus its principal utility as a key screening tool in order to assess children’s general well-being, to identify faltering and excessive growth, to evaluate maternal lactation performance and infant feeding practices, and to manage her children with medical conditions known to adversely affect growth,….” Thus having assessment tools is important. Growth charts are assessment tools measuring height/length, weight, head circumference and body mass index.
Some commonly used growth charts are:
WHO child growth chart standards
They were developed using lo...Source: PediatricEducation.org - February 12, 2018 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news

How dangerous is Jordan B Peterson, the rightwing professor who 'hit a hornets' nest'?Since his confrontation with Cathy Newman, the Canadian academic ’s book has become a bestseller. But his arguments are riddled with ‘pseudo-facts’ and conspiracy theoriesThe Canadian psychology professor and culture warrior Jordan B Peterson could not have hoped for better publicity thanhis recent encounter with Cathy Newman on Channel 4 News. The more Newman inaccurately paraphrased his beliefs and betrayed her irritation, the better Peterson came across. The whole performance, which has since been viewed more than 6m times on YouTube and was described by excitable Fox News host Tucker Carlson as &ldquo...Source: Guardian Unlimited Science - February 7, 2018 Category: Science Authors: Dorian Lynskey Tags: Psychology Politics Science UK news US politics US news The far right World news Online abuse Society US universities Academic experts Identity politics Source Type: news

Mutant, all-female crayfish spreading rapidly through Europe can clone itselfGenome study finds the invasive clonal freshwater crayfish is descended from a single female and reproduces without malesA voracious pest that mutated in a German aquarium and is marching around the world without the need for sexual reproduction may sound like science fiction, but a genetic study has revealed that a rapidly spreading all-female army of crayfish is descended from a single female and reproduces without any males.The clonal freshwater crayfish is regarded as an invasive species which threatens endemic wild species, but its success may help scientists better understand how cancer spreads.Continue reading... (S...Source: Guardian Unlimited Science - February 7, 2018 Category: Science Authors: Patrick Barkham Tags: Invasive species Animal behaviour Biology Conservation Environment Science World news Source Type: news

GE Healthcare launches analytics program for PyeongChang, Tokyo Olympic athletesGeneral Electric (NYSE:GE) said yesterday it is supplying a bespoke advanced analytics solution for both the Olympic Winter Games in PyeongChang this year and the Olympic Games in Tokyo in 2020.
The system, designed through a partnership with the International Olympic Committee, integrates athlete information including injuries and illness alongside venue, sport and training procedures to produce more informed treatment decisions and improve health and safety at the games.
“Through digital transformation, the IOC is pursuing its mission of helping to prevent injuries among our world-class athletes. With 40 ...Source: Mass Device - February 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Software / IT GE Healthcare Source Type: news

How Loud Noise Exposure Is Linked to Heart DiseaseIf you live near an airport, railroad tracks or a busy road, you might be concerned about how fumes from those planes, trains and automobiles are affecting your health. But according to a new review in the Journal of the American College of Cardiology, there may be another threat to worry about: high levels of noise that may be bad for your heart.
A connection between noise pollution and cardiovascular disease has been observed in numerous studies over the years, the authors of the new review said. High decibel levels from road traffic and airplanes, for example, has been linked to high blood pressure, coronary artery dise...Source: TIME: Health - February 6, 2018 Category: Consumer Health News Authors: Amanda MacMillan Tags: Uncategorized are loud noises unhealthy healthytime Heart Disease heart disease risks heart health Journal of the American College of Cardiology noise level meter noise meter noise pollution noise-cancelling headphones onetime Rese Source Type: news

Small errors, fatal consequences(BfR Federal Institute for Risk Assessment) In Germany, every year more than 100,000 cases of illness are statistically recorded whose pathogen can be transferred via food. These reported cases are only the tip of the iceberg, however, as the actual number is estimated to be well over a million. The majority of infections are probably caused by food and for this reason, the proper handling of food in communal catering facilities and restaurants as well as at home is of high importance for avoiding food-borne infections. (Source: EurekAlert! - Infectious and Emerging Diseases)Source: EurekAlert! - Infectious and Emerging Diseases - February 6, 2018 Category: Infectious Diseases Source Type: news

Short TakesThe InterAcademy Partnership (IAP), a global network of academies of sciences and medicine, has released a summary of the workshop on "Assessing the Security Implications of Genome Editing Technology" that was held in Germany in October 2017 and convened by the IAP, US National Academies of Sciences, Engineering, and Medicine, the European Academies Science Advisory Council, and the German National Academy of Sciences Leopoldina. The international workshop brought together global experts in genetic engineering, security studies, and public policy to discuss strategies to mitigate potential security concerns posed...Source: Public Policy Reports - February 5, 2018 Category: Biology Authors: AIBS Source Type: news

Second Sight touts 1st-in-human Orion cortical implantSecond Sight Medical (NSDQ:EYES) today announced the first trial implantation of its Orion cortical visual prosthesis system and updated on implantations of its Argus device and enrollment in an upcoming study.
The first implantation procedure was performed late last month by Dr. Nader Pouratian at the Ronald Reagan UCLA Medical Center, the Sylmar, Calif.-based company said, as part of an FDA-cleared feasibility trial it won approval to launch last November.
The Orion cortical visual prosthesis system is designed to convert images captured by a miniature video camera, mounted on a patient’s glasses, into a ...Source: Mass Device - February 5, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Optical/Ophthalmic Second Sight Source Type: news

Alcohol intoxication in emergency medicine - Wetterling T, Junghanns K.Every year more than 100,000 people with an alcohol intoxication are admitted to German hospitals. Many of them refuse inpatient observation or treatment. Therefore the physician in charge at the emergency room has to decide, how to proceed. The capacity t... (Source: SafetyLit)Source: SafetyLit - February 5, 2018 Category: International Medicine & Public Health Tags: Alcohol and Other Drugs Source Type: news

PSMA PET/CT clearly differentiates prostate cancer from benign tissue(Society of Nuclear Medicine and Molecular Imaging) Using nuclear medicine, German researchers have found a way to accurately differentiate cancerous tissue from healthy tissue in prostate cancer patients. The research is highlighted in the February issue of The Journal of Nuclear Medicine and demonstrates that the maximum standardized uptake value (SUVmax) on 68Ga-PSMA PET/CT scans correlates with PSMA-expression in primary prostate cancer. By this means, researchers were able to generate an SUVmax cutoff for the differentiation of cancerous and benign prostate tissue. (Source: EurekAlert! - Medicine and Health)Source: EurekAlert! - Medicine and Health - February 5, 2018 Category: International Medicine & Public Health Source Type: news

Weight loss surgery improves microvascular complications in obese diabetic patients(Wiley) In a BJS (British Journal of Surgery) analysis of published studies in obese patients with type 2 diabetes, researchers found that weight loss surgery helps prevent the development of microvascular complications--which affect small blood vessels--better than medical treatment. The analysis was conducted by investigators from the Surgical Department of the University of Heidelberg in cooperation with the Study Center of the German Surgical Society. (Source: EurekAlert! - Medicine and Health)Source: EurekAlert! - Medicine and Health - February 5, 2018 Category: International Medicine & Public Health Source Type: news

ReWalk Robotics wins German reimbursement nod for Personal 6.0 exoskeletonReWalk Robotics (NSDQ:RWLK) said this week that the German statutory health insurance head office GKV-Spitzenverband confirmed the listing of the ReWalk Personal 6.0 exoskeleton system in the German medical device directory, which is used for reimbursement from German SHI providers.
The ReWalk 6.0 system will be classified as an “innovative device for the immediate compensation of a handicap” in the directory under a new subcategory, the Marlborough, Mass.-based company said.
ReWalk touted that 90% of Germans are beneficiaries with plans under SHI coverage.
“We are pleased to see the German healthcare sys...Source: Mass Device - February 2, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Prosthetics ReWalk Robotics Source Type: news

TVA Medical touts meta-analysis of everlinQ endoAVF treatmentsTVA Medical today released data from a meta-analysis study of its everlinQ endovascular arteriovenous fistula system designed for hemodialysis access, touting a high procedure success rate and a high rate of fistula maturation.
Results from the 236-patient trial were presented at the Leipzig Interventional Course 2018, the Austin, Texas-based company said.
Data in the meta-analysis came from four clinical studies and 79 commercial cases, and indicated a 96.8% and 97.8% procedure success rate in clinical studies and real-world cases, respectively, as well as an acceptable safety profile.
The results also indicated 88% fistu...Source: Mass Device - February 2, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular TVA Medical Source Type: news

German employee wellness app Humanoo lands $6.4M in fundingDigital health companion app for employees and insured individuals Humanoo recently landed $6.4 million ( €5 million) in funding. The investment was led by Dieter von Holtzbrinck Ventures, and included investments from Creathor Ventures, Rheingau Founders, Rocket Internet, and other investors.
The Berlin-based company plans to use the investment to expand the platform and advance cooperation with he alth insurance companies and insurers. (Source: mobihealthnews)Source: mobihealthnews - February 1, 2018 Category: Information Technology Source Type: news

Neovasc wins German reimbursement for Reducer systemNeovasc (NSDQ:NVCN) said today that it won reimbursement coverage from the German Institute for the Hospital Renumberation System for its Reducer device designed to treat refractory angina.
The Reducer system is designed to alter blood flow in the heart’s circulatory system to increase perfusion of oxygenated blood to ischemic areas of heart muscle, and can be placed in a minimally invasive transvenous procedure, Neovasc said.
The German body gave the device Nub status 1 designation for 2018, the highest priority designation available, up from a previously set Nub 4 status, the Vancouver-based company said....Source: Mass Device - February 1, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Neovasc Inc. Source Type: news

Zurich ’s Air Medical Program Flies Seven ECMO Missions in Ten DaysIn a ten day period in January, Rega aircraft in Zurich, Switzerland transported and cared for a total of seven patients, including a two-year-old child, with the most severe cardiovascular and pulmonary disease.
This was made possible by a small, portable heart-lung extracorporeal membrane oxygenation (ECMO) machine, which is compatible with both the ambulance jets, and the two types of helicopters used by Rega.
Since 2009, Rega has been the only air rescue organization in Switzerland to have its own ECMO equipment. The devices have been instrumental in the care and transport of 25 intensive care patients annually. That&r...Source: JEMS Patient Care - February 1, 2018 Category: Emergency Medicine Authors: A.J. Heightman, MPA, EMT P Tags: Cardiac & Resuscitation Patient Care Operations Source Type: news

Zurich ’s Air Medical Program Flies Seven ECMO Missions in Ten DaysIn a ten day period in January, Rega aircraft in Zurich, Switzerland transported and cared for a total of seven patients, including a two-year-old child, with the most severe cardiovascular and pulmonary disease.
This was made possible by a small, portable heart-lung extracorporeal membrane oxygenation (ECMO) machine, which is compatible with both the ambulance jets, and the two types of helicopters used by Rega.
Since 2009, Rega has been the only air rescue organization in Switzerland to have its own ECMO equipment. The devices have been instrumental in the care and transport of 25 intensive care patients annually. That&r...Source: JEMS Operations - February 1, 2018 Category: Emergency Medicine Authors: A.J. Heightman, MPA, EMT P Tags: Cardiac & Resuscitation Patient Care Operations Source Type: news

It ’s Almost Impossible to Get an Abortion in Poland. These Women Crossed the Border to Germany for HelpDr. Janusz Rudzinski talks on the phone to a woman seeking an abortion as he performs the procedure in Prenzlau, Germany, in March 2017.
It’s Almost Impossible to Get an Abortion in Poland. These Women Crossed the Border to Germany for Help
By ALEXANDRA SIFFERLIN
Photographs by KASIA STREK
Kaja was happy to be pregnant. She had experienced two miscarriages in the past, and was hopeful for her third pregnancy.
But when she started having severe pain, she knew things weren’t going as planned. She was already suffering a host of complications. Her doctor in Poland prescribed her the drug progesterone, meant to for...Source: TIME: Health - January 31, 2018 Category: Consumer Health News Authors: Time Tags: abortion Poland abortion Poland abortion 2017 Poland abortion ban Poland abortion germany Poland abortion laws Poland abortion protest Poland abortion protests Poland abortion statistics Poland black Monday Poland illegal abortion Source Type: news

0.5 percent of the population suffer from severe psychological trauma(University of Zurich) Trauma-related disorders were previously classified under one single diagnosis -- post-traumatic stress disorder. Now, a representative survey carried out by a UZH psychopathologist has shown for the first time how often such disorders are present in a more severe form. According to the findings, more than 0.5 percent of people in Germany suffer from complex post-traumatic stress disorder. (Source: EurekAlert! - Social and Behavioral Science)Source: EurekAlert! - Social and Behavioral Science - January 31, 2018 Category: International Medicine & Public Health Source Type: news

Executives at UCF, Sanford Burnham react to Florida Hospital's decision to bow out of competitionThe University of Central Florida is one step closer to possibly getting the Sanford Burnham Prebys Medical Discovery Institute at Lake Nona now that Florida Hospital has dropped out of the race for the institute's assets.
"If asked by the mayors and Tavistock, we are prepared to move forward with our proposal for a university-based cancer research and treatment center in Medical City," UCF College of Medicine Dean Dr. Deborah German told Orlando Business Journal via email. "If given the opportunity,… (Source: bizjournals.com Health Care News Headlines)Source: bizjournals.com Health Care News Headlines - January 30, 2018 Category: Health Management Authors: Veronica Brezina Source Type: news

Mayors and execs at UCF, Sanford Burnham react to Florida Hospital's decision to bow out of raceThe University of Central Florida is one step closer to possibly getting the Sanford Burnham Prebys Medical Discovery Institute at Lake Nona now that Florida Hospital has dropped out of the race for the institute's assets.
"If asked by the mayors and Tavistock, we are prepared to move forward with our proposal for a university-based cancer research and treatment center in Medical City," UCF College of Medicine Dean Dr. Deborah German told Orlando Business Journal via email. "If given the opportunity,… (Source: bizjournals.com Health Care:Biotechnology headlines)Source: bizjournals.com Health Care:Biotechnology headlines - January 30, 2018 Category: Biotechnology Authors: Veronica Brezina Source Type: news

Mayors and execs at UCF, Sanford Burnham react to Florida Hospital's decision to bow out of raceThe University of Central Florida is one step closer to possibly getting the Sanford Burnham Prebys Medical Discovery Institute at Lake Nona now that Florida Hospital has dropped out of the race for the institute's assets.
"If asked by the mayors and Tavistock, we are prepared to move forward with our proposal for a university-based cancer research and treatment center in Medical City," UCF College of Medicine Dean Dr. Deborah German told Orlando Business Journal via email. "If given the opportunity,… (Source: bizjournals.com Health Care:Physician Practices headlines)Source: bizjournals.com Health Care:Physician Practices headlines - January 30, 2018 Category: American Health Authors: Veronica Brezina Source Type: news